When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $17 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
How You Will Make A Difference.
This positon will be responsible for managing the Corrective and Preventive Action (CAPA) and Non-conformances processes for Thermo Fisher Scientific Laboratory Chemicals, sites in Ward Hill, MA and Tewksbury, MA, in an ISO 9001 environment. The candidate will be responsible for initiating, filing, prioritizing, assigning, assessing, approving and tracking Non-conformances and CAPAs. Risk Analysis experience is a key part of these activities. Project management skills and managing multiple priorities while partnering with multiple departments are a must. Candidate must be a self-starter and able to work with minimal direct oversight. Regular reporting of analytics and metrics will be required.
What You Will Get To Do.
· Manage CAPA System, which includes:
· Review all CAPA submissions
· Assess risk of CAPA submissions and initiate CAPAs
· Assign CAPAs to owners
· Follow up on CAPA status and commitments
· Verify effectiveness of completed CAPAs
· Track CAPA metrics for reporting at Management Review
· Provide Quality Support to Operations by active participation in meetings, addressing quality issues, and ensuring Non-Conformance Reports are appropriately dispositioned.
· Support Operations and Quality Control in the investigation of manufacturing problems and product non-conformances to determine the root cause and recommend appropriate action to prevent recurrence
· Review customer complaints, non-conformance reports and other metrics to identify CAPA opportunities
· Experience with developing and improving nonconformance and CAPA systems
· Hands on experience in using Risk Analysis methodologies in decision making
· Hands on experience with CAPA and non-conformance handling as required by ISO 9001
· Participate in other QMS efforts such as complaints, supplier corrective action, document control, training, supplier quality, etc. as needed
· Major Participant in the Material Review Board (MRB)
· Participate in PPI (continuous improvement) events
· Perform other duties as assigned
· BS in a technical field with at least 5 years of experience in a manufacturing environment. Chemistry background a plus. Significant experience may be considered in place of degree.
· 3 years of active involvement in CAPA and investigation.
· 3 years of experience in Quality Assurance or Quality Control role. Knowledge of the most recent version of the ISO 9001 standard.
· Proficient knowledge of CAPA practices in accordance with ISO 9001 standards.
· Skilled at reporting metrics showing performance and trending; advanced data analysis skills a plus
· Ability to manage numerous priorities and activities in parallel (project management)
· Ability to review current processes and implement productivity and compliance improvements
· Strong “people skills” to be able to deal with various personalities and levels within and outside of the organization.
· Excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.
· Excellent verbal communication skills.
· Excellent organizational skills and be detail oriented.
· Ability to travel between sites in Tewksbury, MA and Ward Hill, MA sites as needed.
Relocation Budget is not approved for this role.
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